Conference Report: Bioanalytical Procedures and Regulation: Towards Global Harmonization

Author:

Hill Howard M1

Affiliation:

1. Huntingdon Life Sciences, Woolley Road, Alconbury, Cambridgeshire, PE28 4HS, UK.

Abstract

The session on Bioanalytical Procedures and Regulation Towards Global Harmonization at the American Association of Pharmaceutical Scientists – Pharmaceutical Sciences World Congress meeting was organized by Mark Arnold (Bristol-Myers Squibb, NY, USA) who co-chaired with Brian Booth (US FDA) and Howard Hill (Huntingdon Life Sciences, Cambridgeshire, UK). The session continued the ongoing discussions and debate around harmonization of bioanalytical regulations in today’s globalized pharmaceutical development arena.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference11 articles.

1. Building the Global Bioanalysis Consortium – working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation

2. US FDA. Guidance for industry: bioanalytical method validation. US Department of Health and Human Services. US FDA CDER, MD, USA (2001).

3. European Medicines Agency. Concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods. EMEA/CHMP/EWP/531305/2008 (2008).

4. European Medicines Agency. Draft guideline on the validation of bioanalytical methods. EMA, Committee for Proprietary Medicinal Products (Committee for Medicinal Products for Human use), London, UK (2009).

5. Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance

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